BIOTRONIK Announces Conclusion of Full-Body ProMRI Pacemaker Study

December 09, 2014 08:35 AM Eastern Daylight Time

LAKE OSWEGO, Ore.--(EON: Enhanced Online News)--BIOTRONIK, a leading manufacturer of cardiovascular medical technology,
announced today that Phase B of its ProMRI® study has
completed patient enrollment and concluded all planned scans. This phase
of the study is investigating the safety of Entovis pacemakers in
patients who undergo full-body magnetic resonance imaging (MRI) scans,
including cardiac and thoracic spinal scans.

“The majority of current pacemakers are not approved for use in the MRI
environment due to safety concerns”

The BIOTRONIK ProMRI study consists of a series of ground-breaking MRI
compatibility trials; all intended to increase cardiac device patients’
access to this diagnostic tool. Phase A of the trial resulted in FDA
approval of Entovis pacemaker systems for MRI scans with an
exclusion zone. Phase C, still ongoing, incorporates Iforia ICD and DX
systems into the list of devices being investigated for full-body MRI
scans.

“The majority of current pacemakers are not approved for use in the MRI
environment due to safety concerns,” said Luba Frank, MD, Assistant
Professor of Radiology, University of Michigan Medical Center, Ann
Arbor, MI. “Completion of these trials will be an important milestone
towards improving access to MRI scans and improving diagnosis and
treatment of these patients.”

There are more than 6.5 million pacemaker patients worldwide,1
and more than one million are implanted each year.2 Until
recently, patients with a pacemaker or ICD were denied MRI scans due to
concern that the strong magnetic fields and radio waves created by an
MRI could have a negative effect on both the implanted device and the
patient. With its ProMRI technology, BIOTRONIK has developed a solution
that will enable all cardiac rhythm patients to have access to important
MRI scanning.

The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject
recruitment since March 2013.

About BIOTRONIK

One of the world’s leading manufacturers of cardio- and endovascular
medical devices, BIOTRONIK is headquartered in Berlin, Germany, and
represented in over 100 countries by its global workforce of more than
5,600 employees. Several million patients have received BIOTRONIK
implants designed to save and improve the quality of their lives, or
have been treated with BIOTRONIK coronary and peripheral vascular
intervention products. Since its development of the first German
pacemaker in 1963, BIOTRONIK has engineered many innovations, including
BIOTRONIK Home Monitoring®; the world’s first 4 F-compatible
200 mm peripheral stent*; Orsiro, the industry’s first hybrid
drug-eluting stent*; and the world’s first implantable cardioverter
defibrillators with ProMRI® technology*.